How Nye Metoder works
Nye Metoder is the national system for introducing new methods in Norway's specialist health service. For a new medicine or indication, the supplier sends a request for assessment to the Nye Metoder secretariat no earlier than Day 120 of the EMA procedure (Day 1 for extensions of indication and accelerated assessments). The request is published, and it states what documentation the supplier plans to send to DMP and when.[1]
Bestillerforum, made up of the medical directors of the four regional health authorities and two representatives of the Norwegian Directorate of Health, meets monthly and commissions the work: a single technology assessment (STA), a broader HTA or a price note. DMP prepares a suitability assessment beforehand and carries out STAs of medicines. Sykehusinnkjøp HF holds price discussions with the supplier, and Beslutningsforum, the four regional chief executives, decides whether the method is introduced.
Two simplified routes avoid a full STA. Sykehusinnkjøp can ask a specialist group for an early assessment of comparability with a medicine already introduced for the same indication, and PD-(L)1 inhibitors can join a scheme in which an annual cost below a set price cap can allow introduction without an STA.
Outpatient medicines follow a separate route: DMP assesses them for reimbursement through the National Insurance Scheme (blue prescription), where the documentation must meet section 14-4 of the medicines regulation.
- From EMA Day 120Request for assessmentSupplier sends the request to the Nye Metoder secretariat; it is published
- MonthlyBestillerforum commissionsSingle technology assessment, broader HTA or price note
- At least 3 months' noticeDocumentation to DMPValidated within 14 days against must and should requirements
- AssessmentDMP single technology assessmentBenefit, resource use and severity (absolute shortfall)[2]
- PriceSykehusinnkjøp price discussionsSupplier and Sykehusinnkjøp HF
- DecisionBeslutningsforumThe four regional chief executives decide on introduction
Preparing the documentation package
DMP's submission guideline was updated with effect from 6 July 2026 to separate must requirements from should requirements, and the submission template now follows the structure of DMP's own report. The key procedural rules are:[3]
- Notification: once Bestillerforum has commissioned an STA, the supplier gives DMP the planned submission week at least three months ahead, and reports any delay no later than two weeks before the agreed date.
- Validation: DMP checks the dossier within 14 days. If a must requirement is not met, the documentation counts as not received and the case does not start. A missed should requirement can lead to a clock stop.
- Deadline: if documentation has not arrived 12 months after the request, the commission can be cancelled.
- Scope: documentation covers the whole authorised or applied-for indication, and any proposed subgroup comes on top of that.
- Language and format: the guideline is in English, and dossiers may be in Norwegian, Swedish, Danish or English. DMP asks for tables as real tables, not images, and any use of AI must be disclosed.
- Literature: the final search date for mandatory sources must be no more than six months before submission.
Pre-submission meetings are optional, held on Teams and last about an hour. The agenda goes in one to two weeks ahead and must set out the PICO choices to discuss. DMP's views are not binding and no agreed minutes are produced.
Economic evaluation methods
- Perspective: an extended health-service perspective. Effects on the patient's lifespan and quality of life must be included; caregiver quality of life may be, with results shown with and without it. Costs include treatment, travel, and patient and caregiver time. Productivity changes and transfer payments are excluded.
- Time horizon: long enough to capture all important differences, and the patient's expected lifetime if mortality is affected.
- Discounting: 4% a year for years 0 to 39, 3% for years 40 to 74 and 2% thereafter.
- Costs: Norwegian unit costs, with medicines at the maximum pharmacy retail price excluding VAT, and a model that allows the price to be changed for discount analyses.
- Utilities: the Norwegian EQ-5D-5L value set (Garratt et al., 2024) has been mandatory for adults in new submissions since 1 September 2025, together with updated norm data for age adjustment and severity.
See model adaptation for moving a global model onto these settings.
Severity: absolute shortfall in Norway
Norway sets priorities on three criteria, benefit, resource use and severity, weighed together. Severity is measured as absolute shortfall: the healthy life years a patient group loses, with current standard treatment, compared with the general population of the same age. It is required in every cost-utility analysis and is calculated in four steps:
- The mean age at treatment start in the Norwegian patient group.
- Expected remaining undiscounted QALYs for the general population at that age.
- The undiscounted prognosis in QALYs for the patient group under current standard treatment.
- Absolute shortfall as the difference between the two.
DMP compares the cost per QALY with the opportunity cost of NOK 275,000 per QALY. There is no absolute limit: the more severe the condition, the more resources can be accepted, while large uncertainty and large budget impact can lower priority. For particularly small patient groups with very severe conditions, a lower evidence requirement and higher resource use can be accepted. The guiding criteria are fewer than about one patient per 100,000 worldwide and fewer than about 50 patients in Norway, an absolute shortfall of at least about 30 QALYs, and an expected gain of at least about two QALYs.
| 1. Mean age at treatment start in the Norwegian patient group | 60 years |
| 2. Expected remaining undiscounted QALYs, general population at 60 | 18.0 |
| 3. Undiscounted prognosis on current standard treatment | 6.0 QALYs |
| 4. Absolute shortfall | 18.0 − 6.0 = 12.0 QALYs |
An absolute shortfall of 12 QALYs is then weighed with benefit and resource use; the more severe the condition, the more resources can be accepted.
Figures are invented for illustration and follow the four steps in the DMP submission guideline. Real calculations use the Norwegian population data specified in DMP's guidance.
Calculate absolute shortfall with the current Norwegian norms in our free calculator.
Open the norway severity calculatorHow the EU JCA interacts with Nye Metoder
Regulation (EU) 2021/2282 applies in Norway through the EEA Agreement, and Nye Metoder received its first medicines that had been through a joint clinical assessment in 2026. The JCA covers relative effectiveness and safety. Health economics and the decision on introduction stay national.[4]
- Suppliers must still send a request for assessment to Nye Metoder.
- DMP is responsible for Norway's PICO input and offers dialogue on the Norwegian PICO, plus pre-submission meetings on the extra documentation a national STA needs.
- Documentation can be sent before the JCA report is public, but DMP does not start formal handling until it is.
- DMP's templates show which parts of the dossier the JCA now covers.
See EU JCA dossiers and our Nordic HTA overview.
What we deliver
- Requests for assessment, timed to the EMA procedure and written to support the right type of commission
- DMP documentation packages built to the July 2026 template and checked against every must requirement before submission
- Cost-utility models with the extended health-service perspective, stepped discount rates and Norwegian unit costs
- Absolute shortfall calculations consistent with the model, using current norm data
- Utility analyses using the Norwegian EQ-5D-5L value set, with mapping where trial data use another instrument
- Systematic reviews and indirect treatment comparisons that serve both the JCA and the national STA
- Preparation for pre-submission meetings and analysis to support price discussions with Sykehusinnkjøp
What to get right
- Every must requirement: A dossier that meets them all is received as planned and keeps its start slot.
- Timely notification: DMP recruits clinical experts from the notification, so an on-time notice secures assessment capacity.
- Consistent ages and prognoses: The age in the severity calculation, the model and Norwegian practice should match.
- The Norwegian value set: Adult submissions use the Norwegian EQ-5D-5L tariff that DMP requires.
- The full population, then subgroups: A proposed restriction is documented alongside the whole indication.
Why Evidaxia
Our EU-level work, covering EU JCA dossiers, PICO scoping, indirect comparisons and network meta-analyses, and global model adaptation, is built to feed national processes such as Nye Metoder, and we bring that experience to Norwegian submissions. Our founder worked on the assessor's side at NICE as an HTA Technical Lead and Analyst, so we build documentation packages the way assessors read them.
References
- Nye Metoder. For suppliers [Internet]. Oslo: Nye Metoder; [date unknown] [cited 2026 Oct]. Available from: https://www.nyemetoder.no/en/english/for-suppliers/
- Direktoratet for medisinske produkter (DMP). Priority criteria (resource use, benefit, severity) [Internet]. Oslo: Direktoratet for medisinske produkter (DMP); [date unknown] [cited 2026 Oct]. Available from: https://www.dmp.no/offentlig-finansiering/offentlig-finansiering-av-legemidler-og-medisinsk-utstyr/hva-inneberer-prioriteringskriteriene-ressursbruk-nytte-og-alvorlighet
- Direktoratet for medisinske produkter (DMP). Submission guideline [Internet]. Oslo: Direktoratet for medisinske produkter (DMP); 2026 Jul [cited 2026 Oct]. Available from: https://www.dmp.no/globalassets/documents/offentlig-finansiering-og-pris/dokumentasjon-til-metodevurdering/submission-guideline-july-2026.pdf
- Direktoratet for medisinske produkter (DMP). EU regulation on health technology assessment [Internet]. Oslo: Direktoratet for medisinske produkter (DMP); [date unknown] [cited 2026 Oct]. Available from: https://www.dmp.no/offentlig-finansiering/metodevurdering-av-medisinske-produkter/internasjonalt-samarbeid/eu-forordning-om-metodevurdering
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.